Dave Nelson
Rocky Top Vapor, LLC
105 Kwick Way Ln
Johnson City , TN 37615
United States
rockytopvapor@gmail.com
orders@rockytopvapor.com
wholesale@rockytopvapor.comFEI 3013362285Issued Apr 9, 2021Center for Tobacco Products
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013362285.
Violations1
Issue DateApr 9, 2021
Product TypeTobacco
StatusClosed
Closeout LetterJul 20, 2021
Letter Details
Firm
Rocky Top Vapor, LLC
Location
Dave Nelson
Rocky Top Vapor, LLC
105 Kwick Way Ln
Johnson City , TN 37615
United States
rockytopvapor@gmail.com
orders@rockytopvapor.com
wholesale@rockytopvapor.com
FEI Number
3013362285
Country
United States
Issue Date
April 09, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Closed
Closeout Letter
July 20, 2021
Summary
Rocky Top Vapor, LLC was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquids, offered for sale through their website, were deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act and fell under FDA jurisdiction as of August 8, 2016, but lacked the legally mandated marketing authorization order necessary for new tobacco products. The violation centered on the company's failure to comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which requires premarket approval before any new tobacco product can be legally marketed in the United States.
Rocky Top Vapor, LLC FDA Warning Letter, April 9, 2021